App-Delivered Sleep Coaching for Cancer

(ACCESS Trial)

Overseen By Marjorie A Nelson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Prescription sleep medications

Disqualifiers: Pregnancy, Psychiatric conditions, Shift work, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a smartphone or tablet app in helping cancer survivors and their bedroom partners improve sleep. Participants will receive either digital sleep coaching or access to educational information about sleep for eight weeks. The trial seeks individuals diagnosed with any type of cancer who completed treatment six months to five years ago and frequently experience sleep difficulties. Eligible participants should have a consistent bedroom partner who has not had cancer in the past five years.

As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance sleep quality for cancer survivors and their partners.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed the type or dose of any prescription sleep medications in the past three months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using an app for sleep coaching offers a promising way to help people with insomnia. Although detailed safety information for app-based sleep coaching is lacking, studies have found it increases accessibility, particularly for cancer survivors. This makes it easier for more people to use.

The app incorporates techniques from cognitive behavioral therapy for insomnia (CBT-I). These techniques have been tested and proven effective by research. They include activities and discussions to improve sleep habits. Importantly, these methods are generally well-tolerated, with few negative reactions reported.

Delivering this treatment through an app avoids some risks associated with medication-based treatments, making it a low-risk option for many. While specific side effects aren't detailed, the approach appears safe based on its widespread use and acceptance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help cancer patients improve their sleep. Unlike traditional sleep aids, which often involve medication, this trial focuses on non-drug approaches. The sleep coaching program is delivered via a smartphone or tablet app, making it easily accessible and personalized. Additionally, the sleep education component provides participants with valuable knowledge about sleep health, empowering them to make informed decisions about their sleep habits. This trial aims to find out if these digital tools can effectively enhance sleep quality for cancer patients, offering a convenient and safe alternative to current treatments.

What evidence suggests that this trial's sleep interventions could be effective for cancer survivors?

Research has shown that using an app for sleep coaching can improve sleep for cancer patients. In this trial, participants in the sleep coaching group will engage in an 8-week program via the Mi Sleep Coach app, specifically designed for cancer-related sleep issues. One study found that app users fell asleep 11 minutes faster and stayed asleep 28 minutes longer after waking during the night. They also spent 6.6% more time asleep while in bed, with total sleep time increasing by about 44 minutes. These findings suggest that a sleep coaching app on a smartphone or tablet could enhance rest for cancer survivors. Meanwhile, participants in the sleep education group will receive electronic access to educational information about sleep for 8 weeks. ^{1 4 6 7 8}

Who Is on the Research Team?

Rina S. Fox, PhD, MPH

Principal Investigator

University of Arizona College of Nursing

Are You a Good Fit for This Trial?

This trial is for cancer survivors and their partners who share a bedroom. It's designed to see if they can join and stay in a study that tests digital sleep help tools.

Inclusion Criteria

Score 8 to 14 on the Insomnia Severity Index (ISI)

I finished my cancer treatment between 6 months and 5 years ago, except for ongoing hormone therapy.

Have a consistent bedroom partner (i.e., sleep in the same bedroom 4 or more nights per week)

Exclusion Criteria

My sleep medication type and dose have been the same for the last 3 months.

Not planning to travel across 3 time zones or more during the eight intervention weeks or for the two weeks leading up to study assessments

Not pregnant at enrollment or planning to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week sleep coaching program delivered by smartphone/tablet app or electronic access to educational information about sleep

8 weeks

Follow-up

Participants are monitored for satisfaction and changes in sleep health, insomnia symptoms, and symptom burden immediately after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep coaching
• Sleep education

Trial Overview The study is looking at how well an app that provides sleep coaching works compared to one that just gives information about sleep. The goal is to improve the quality of rest for both cancer survivors and their partners.

How Is the Trial Designed?

Group I: Sleep coaching Experimental Treatment 1 Intervention

Participants will receive an 8-week sleep coaching program delivered by smartphone/tablet app

Group II: Sleep education Active Control 1 Intervention

Participants will receive electronic access to educational information about sleep for 8 weeks

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

Cancer-related fatigue may be linked to disrupted sleep and irregular sleep/wake cycles, suggesting that improving sleep quality could help alleviate daytime fatigue in cancer patients.

Inadequate or unrefreshing sleep not only contributes to fatigue but also affects the overall quality of life, treatment tolerance, and may lead to mood disorders in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between fatigue and sleep in cancer patients: a review. Ancoli-Israel, S., Moore, PJ., Jones, V.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06938802

Pilot Study of App-delivered Sleep Coaching Among ... The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11087861/

Mi Sleep Coach Mobile App to Address Insomnia ... The Mi Sleep Coach app is a promising intervention for cancer-related insomnia, and further clinical trials are warranted.

3. formative.jmir.org formative.jmir.org/2024/1/e55402

Mi Sleep Coach Mobile App to Address Insomnia Symptoms ... The Mi Sleep Coach app is a promising intervention for cancer-related insomnia, and further clinical trials are warranted.

4. withpower.com withpower.com/trial/phase-neoplasms-3-2025-05bba

App-Delivered Sleep Coaching for Cancer (ACCESS Trial) The research does not provide specific safety data for app-delivered sleep coaching, but it highlights that sleep disturbances are common in cancer patients ...

5. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2023.1156844/full

App-supported sleep coaching: implications for ... Results: Mean SL was reduced by 11 min, mean WASO was reduced by 28 min, mean SE% increased by 6.6%, and mean TST increased by about 44 min. Of those who ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12456873/

Development of a Mobile App (iCANSleep) to Treat Insomnia ... The primary advantage identified by cancer survivors for receiving insomnia treatment through a smartphone app was increased accessibility.

7. link.springer.com link.springer.com/article/10.1007/s13187-025-02770-4

A Phase II Pilot Study | Journal of Cancer Education Outcomes included total sleep time, sleep efficiency, and wake after sleep onset. Cancer-Related Health Outcomes. Participants completed the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04827459

Sleep Coach: A Mobile App to Address Insomnia ... The Sleep Coach app includes evidence-based CBT-I strategies, interactive activities and a computerized dialogue agent to engage users in the adoption of and ...